A Phase III, Multicenter, Randomized, Double‑Masked, Sham‑Controlled Study To Investigate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of RO7200220 Administered Intravitreally In Patients With Uveitic Macular Edema
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 225
- 试验地点
- 7
- 主要终点
- Proportion of participants with 15 letter improvement from baseline in BCVA at Week 16
研究概览
简要总结
The purpose of this studyis to assess the efficacy, safety, pharmacokinetics, and pharmacodynamicsof RO7200220, a novel recombinant, humanized anti interleukin 6 (IL6) monoclonal antibody. RO7200220 is administered by intravitreal (IVT)injection in patients with uveitic macular edema, a sight threateningcomplication of non infectious uveitis (NIU) (hereafter referred to asuveitic macular edema secondary to NIU and will be referred to as “UME”).Systemic or local (IVT or periocular) corticosteroid therapies are themost common treatments for UME but are associated with significant adverse effects. There is an unmet need foreffective non steroidal therapies for UME that do not have corticosteroidrelated adverse effects and that have an improved or positive benefit riskbalance for treatment of patients with UME.
Globally LPI achieved on 11 Dec 2024 with 256subjects enrolled
India LPI achieved on 25 Nov 2024 with 07subjects enrolled
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosis of non infectious uveitis (NIU) of any anatomical type (anterior, intermediate, posterior, panuveitis)
- •Active and inactive NIU is allowed.
- •Macular edema due to NIU defined as CST more than equal to 325 um on Spectralis SD-OCT or more than equal 315 um on Topcon or Cirrus at screening evaluated by CRC
- •BCVA letter score of 73 to 19 letters (both inclusive) on ETDRS-like charts (20 OR 40 to 20 OR 400 Snellen equivalent) at Day 1.
排除标准
- •Pregnancy or breastfeeding, or intention of becoming pregnant during the study
- •Evidence of active or latent syphilis infection
- •Evidence of active or latent tuberculosis infection, or previous or current HIV diagnosis
- •Serious acute or chronic medical illness
- •Blood transfusion within 12 months prior to screening
- •Any major non‑ocular surgical procedure within 1 month prior to Day 1 7.Any febrile illness within 1 week prior to Day 1
- •Any known hypersensitivity to fluorescein, dilating eye drops, or topical anesthetic eye drops.
结局指标
主要结局
Proportion of participants with 15 letter improvement from baseline in BCVA at Week 16
时间窗: From baseline to Week 16
次要结局
- 1. Proportion of participants with 15 letter improvement from baseline in BCVA at Week 20 (8 weeks after the final study drug dose)(2.Change from baseline in CST (central subfield thickness)at Week 16.)
- Other Secondary Outcomes(1.Change from baseline in BCVA and CST at Weeks 20 and 52)
- PK/ PD Outcome(1. AH concentration)